EASD: Pump Plus Glc Monitor Has Low Hypoglycemia Risk

Action Points

Note that these studies were published as abstracts and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Explain to interested patients that sensor-augmented pump therapy -- the foundation of the so-called "artificial pancreas" -- is better than daily insulin injections at improving glycated hemoglobin (HbA1c) without increasing the risk of hypoglycemia among adults.

Note that closed-loop therapy with a new safety algorithm software program reduced the incidence of hypoglycemia twofold in a pilot study.

STOCKHOLM -- Sensor-augmented pump therapy -- the foundation of the so-called "artificial pancreas" -- is better than daily insulin at improving glycated hemoglobin without increasing hypoglycemia risk among adults, according to researchers.

A one-year randomized trial that included more than 320 adults found that those on augmented pump therapy had a greater drop in HbA1c than those on multiple daily injections of insulin -- a treatment difference of 0.6%, significant at P<0.001, Jennifer Green, MD, of Duke University, and colleagues, reported.

"Sensor-augmented pump therapy resulted in greater improvements in A1c, and a larger percentage reached A1c goals," Green said during an oral session at the European Association for the Study of Diabetes meeting here.

"Rates of severe hypoglycemia were similar, there was a low incidence of diabetic ketoacidosis, and there was no difference in weight gain," she added at the session, which included a discussion of research on laying the groundwork for the artificial pancreas.

Sensor augmented pump therapy combines an insulin pump with real-time continuous glucose monitoring. An "artificial pancreas" would also include an algorithm that could automatically signal the pump to add or withhold insulin as necessary, depending on blood sugar levels.

Green's results came from the STAR 3 study, a one-year multicenter randomized controlled trial that compared the sensor-augmented therapy with multiple daily injections of insulin glargine and insulin aspart.

While those reported results encompassed data on 485 adults and children combined, Green and colleagues' current analysis focused on the 329 adult STAR 3 patients.

They found that the decline in HbA1c was significantly greater in the sensor-augmented pump therapy group, falling from 8.3% to 7.3%. Among those on injection therapy, HbA1c fell from 8.3% to 7.9%. The treatment difference was 0.6% (P<0.001).

As well, a greater proportion of patients on the sensor-augmented therapy achieved American Diabetes Association targets for HbA1c compared with the injection therapy group (34.3% versus 11.7%, P<0.001).

Mean sensor glucose was also significantly lower in the sensor group at both six months and one year (P<0.01).

And the improvements came at little cost -- with no increase in severe hypoglycemia or in the time spent with blood glucose below 70 mg/dL after a year, Green added.

There were no significant differences between groups in the incidence of diabetic ketoacidosis; there were two episodes in the sensor-augmented group and none in the daily injections group.

Nor was there any difference in weight gain between the two groups.

Green said that a number of factors predicted which patients would achieve the greatest benefits from sensor-augmented pump therapy: those with a higher baseline HbA1c, those who were older when they enrolled in the study, and those who had an older age at diagnosis.

During that oral session, researchers also reported that a new safety algorithm in a closed-loop system appeared better at keeping patients in a target glucose range overnight.

"You can increase the time spent in normal glycemia overnight and can decrease nocturnal hypoglycemia," said Eric Renard, MD, PhD, of CHU Montpellier and University of Montpellier in France.

Physicians have raised safety concerns about hypoglycemia with closed-loop systems, so researchers developed a "Safety Supervision Module."

They tested the new software in a pilot study of six patients (mean age 43) at the CHU Montpellier Clinical Research Center. Patients were monitored after they had exercised and eaten, and had their blood glucose tested during different periods.

Patients exercised for a half-hour at 4 p.m., ate a 70-gram carbohydrate meal at 7 p.m., and a 20-gram carbohydrate snack at 10:30 p.m.

Reference blood glucose was measured every 30 minutes from 2 p.m. until 11 p.m., and every hour from 12 a.m. to 8 a.m. the next morning.

The researchers found that, compared with standard pump therapy, closed-loop therapy with the new safety algorithm reduced the incidence of hypoglycemia two-fold -- from 13 to six events.

The pilot study also found that mean blood glucose levels were similar for both periods, but the percentage of time spent in the target range was better during the closed-loop system than with standard pump therapy.

"Patients spent twice as less time in hypoglycemia and in hyperglycemia thanks to this safety module," Renard said, adding that the addition of the safety algorithm reduced hypoglycemia even "during challenging conditions such as physical exercise."

He concluded that adding this safety algorithm "is an effective tool to improve keeping glucose control in a safe range," but called for larger trials to confirm the benefits of the added safety provided by the algorithm.

The STAR 3 study was supported by Medtronic. Green said she had relationships with VeroScience, Takeda, and Merck.

The pilot study was supported by the Juvenile Research Diabetes Foundation. The devices were provided by Insulet, and Abbott Diabetes Care. Renard said he had no relationships relevant to the study.

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